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    Summary
    EudraCT Number:2021-002179-21
    Sponsor's Protocol Code Number:AB21004
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-002179-21
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 study to evaluate the safety and efficacy of masitinib as add-on therapy in patients with mild to moderate Alzheimer's disease, treated with standard of care : cholinesterase inhibitors, memantine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 study to evaluate the safety and efficacy of masitinib as add-on therapy in patients with mild to moderate Alzheimer's disease treated with standard of care: cholinesterase inhibitors, memantine
    A.4.1Sponsor's protocol code numberAB21004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAB Science
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointAlain Moussy
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033147202311
    B.5.5Fax number0033147202411
    B.5.6E-mailregulatoryaffairs@ab-science.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMasitinib mesilate
    D.3.9.1CAS number 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMasitinib
    D.3.2Product code AB1010
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMasitinib mesilate
    D.3.9.1CAS number 790299-79-5
    D.3.9.4EV Substance CodeSUB32266
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.1
    E.1.2Level LLT
    E.1.2Classification code 10086384
    E.1.2Term Early onset Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate whether masitinib treatment will show a significant improvement ADCS-ADL and ADAS-Cog versus placebo in the study patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the efficacy of masitinib compared with placebo on a range of clinical parameters of Alzheimer's disease. The secondary objectives also include the assessment of safety and tolerability of masitinib as compared to placebo in terms of adverse events, vital signs, physical examination, ECG, and clinical laboratory tests.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with clinical diagnosis of Alzheimer's disease based on cognitive impairment and daily functional dependency at screening visit
    2. Patient with ADCS-ADL score at screening visit and baseline visit <73

    3. Patient with MMSE ≥ 14 and ≤ 25 at screening visit and baseline visit

    4. Patient with Alzheimer’s Disease biomarker profile at screening visit:
    - A positive amyloid PET scan
    - Alternatively, a-beta 1-42 <1000pg/ml AND p-tau >19pg/ml OR a p-tau/a-beta ratio > 0.024, as measured by a central laboratory according to the Elecsys assay for CSF biomarkers

    5. Patients treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) at baseline visit, and/or a stable dose of memantine for a minimum of 6 months at baseline visit, with no changes foreseen in therapy throughout the study

    6. If receiving a supplement for cognition (eg, gingko biloba, omega-3 polyunsaturated fatty acid, vitamin E, curcumin, souvenaid) must be taking a stable dose for at least 4 months prior to screening visit

    7. Patients with a caregiver who, at screening visit and baseline visit:
    - Agrees to accompany the participant to all study visits and able to supervise the participant's compliance with the study procedures and provide detailed information about the participant.
    - Either lives with the participant or sees the participant on average for ≥1 hours/day ≥3 days/week, or in the Investigator's opinion, the extent of contact is sufficient to provide meaningful assessment of changes in participant behaviour and function over time and provide information on safety and tolerability.
    - Is able to read, understand, and speak the designated language at the study centre.
    - Caregiver must be cognitively able to fulfil the requirements of the study.

    Other inclusion criteria
    8. Male or non-pregnant female adult ≥50 years of age at time of enrolment at screening visit

    9. Patients with bodyweight >45 kg and BMI between 18 and 35 kg/m2 at screening visit or baseline visit

    10. Contraception, at screening and baseline visit:
    Female patients of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agree to use a highly effective method of contraception and an effective method of contraception by their male partner during the study and for 3 months and a half after the last treatment intake
    Male patients with a female partner of childbearing potential who agree to use a highly effective method of contraception and an effective method of contraception by their female partner during the study and for 3 months and a half after the last treatment intake OR who agree to use an effective method of contraception and a highly effective method of contraception by their female partner during the study and for 3 months and a half after the last treatment intake.

    Highly effective and effective methods of contraception are detailed in the Appendix 14.1 of the protocol.

    11. Subjects must be able and willing to comply, both at screening visit and at baseline visit, with study visits and procedures

    12. Subjects able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures

    13. Subjects able to understand, and willing to follow the safety procedures mentioned on the patient card in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, at screening and baseline visit. Patient card will be provided at baseline visit
    E.4Principal exclusion criteria
    1. Patients with any other cause of dementia shown by MRI findings and neurological examination in the last 12 months prior to screening visit
    2. Systemic conditions known to cause dementia, e.g., hypothyroidism, untreated vitamin B12 or folic acid deficiency, niacin deficiency, neurosyphilis, HIV infection at screening visit
    3. Patients with substance-induced dementia at screening visit
    4. Patients with Alzheimer’s disease with delirium at screening visit
    5. Patients with severe forms of delusions (e.g, NPI delusion score of 4 or more) at screening visit
    6. Patients with evidence of psychosis and/or use of antipsychotic drugs at screening, or history of significant psychiatric disorder at screening visit
    7. Patients with hypersensitivity to masitinib or its excipients at screening
    8. Patients with history (or family history) of drug-induced severe skin toxicities or reactions at screening or patients taking concomitant treatment or therapies associated with severe drug-induced skin toxicity

    9. Patients with history of severe bone marrow disorders such as agranulocytosis or aplasia, or with abnormal laboratory results from local laboratory assessments at screening and baseline defined as:
    - Neutropenia with ANC <1.5 × 109/L
    - Anemia with Hgb <10 g/dl
    - Thrombocytopenia with platelet counts <75 × 109/L

    10. Patients with history of severe hepatic disorders, such as viral hepatitis or steatohepatitis, and alcoholic steatosis, or with abnormal laboratory results defined as:
    - Hepatic transaminase levels >2 ULN at baseline, or
    - Total bilirubin level >1.5 ULN at baseline, or
    - Both hepatic transaminase levels and total bilirubin level outside of the normal ranges at screening and baseline, or
    - Albuminemia <1 × LLN at screening and baseline, or
    - Patients with concomitant medication known to be associated with severe hepatotoxicity

    11. Patients with pre-existing severe renal impairment, or with abnormal laboratory results at screening:
    - Creatinine clearance <60 mL/min (Cockcroft and Gault formula) or
    - Proteinuria >30 mg/dL (1+) on dipstick; in case of the proteinuria ≥1+ on the dipstick, 24 hours proteinuria must be >1.5 g/24 hours

    12. Patients with current or history of severe cardiovascular disease, assessed at screening:
    - Myocardial infarction
    - Unstable angina pectoris
    - Coronary revascularization procedure
    - Congestive heart failure of NYHA Class III or IV
    - Stroke, including a transient ischemic attack
    - Second degree or third-degree atrioventricular block not successfully treated with a pacemaker
    - Bi-fascicular block
    - QTc Fridericia interval > 450 milliseconds for males and > 470 milliseconds for females
    - Drug induced heart failure or ischemic heart disease
    - Radiotherapy induced cardiomyopathy
    - Family history of unexpected death of cardiovascular origin
    - Edema of cardiac origin and left ventricular ejaculation fraction ≤50%

    13. Patients, with two or more of the risk factors listed below assessed by a cardiologist at screening as Very High Risk (calculated SCORE* ≥10%.) according to the Systematic Coronary Risk Estimation (SCORE*):
    - Hypertension (uncontrolled)
    - Diabetes
    - Kidney disease
    - Current smoking (≥ 10 Pack-year: equivalent to 1 pack of 20 cigarettes for 10 years with the formula N (number of packs of 20 cigarettes smoked daily) × T (number years smoking)) Patients who stopped smoking 6 months prior to the evaluation, are not concerned.
    - Hypercholesterolemia,
    - COPD
    * This assessment is done according to the Systematic Coronary Risk Estimation (SCORE) using the country specific free full version of HeartScore®, the interactive tool for predicting and managing the risk of heart attack and stroke in Europe, available at https://www.heartscore.org/en_GB/access
    If the country specific version is not available, EU one should be used.


    19. Pregnant, or nursing female patients at screening or baseline

    20. Patients with a diagnosis of cancer or evidence of continued disease within five years before screening
    22. Patient who has been exposed to an investigational treatment within 3 months (9 months for immunotherapies) or five half-lives of an investigational product, whichever is longer, before the screening visit
    23. Subjects who have received a live vaccine within 30 days prior to first IMP administration
    E.5 End points
    E.5.1Primary end point(s)
    The study has two following primary endpoints:
    • Absolute change from baseline in ADCS-ADL score at week 24
    and
    • Absolute change from baseline in ADAS-Cog score at week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    E.5.2Secondary end point(s)
    The key secondary endpoint consists of:
    • Time to severe dementia (MMSE<10)
    The secondary endpoints of the study are:
    • Absolute change from baseline in ADAS-Cog score at week 48
    • Absolute change from baseline in ADCS-ADL score at week 48
    • Clinical Responder rate at Week 24.
    • Clinician’s Interview Based Impression of Change-plus (CIBIC-plus) at Week 24
    • Mini-Mental State Examination (MMSE) at Week 24
    • Clinical Dementia Rating (CDR) at Week 24
    • Neuropsychiatric Inventory (NPI) at Week 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 24, week 48
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    cholinesterase inhibitors (donepezil, rivastigmine, or galantamine), memantine
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA155
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Canada
    Colombia
    Israel
    Peru
    South Africa
    United States
    Finland
    France
    Poland
    Sweden
    Bulgaria
    Netherlands
    Romania
    Spain
    Switzerland
    Czechia
    Germany
    Greece
    Italy
    Belgium
    Denmark
    Ireland
    Norway
    Portugal
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Visit Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 576
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-20
    P. End of Trial
    P.End of Trial StatusOngoing
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